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Completed

NCT Number: NCT01003574

Evaluation of Cardiovascular Health Outcomes Among Survivors

This study will test a 2-tiered tailored intervention and evaluation of cardiovascular health outcomes among survivors designed to inform childhood cancer survivors about their individual cardiac risk and follow-up recommendations and to provide motivational support for cardiovascular (CV) screening. This study will test if the addition of telephone motivational interviewing, tailored to behavioral constructs, is superior to the current standard of care in increasing survivors' CV screening.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St . Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

  • This study will test the hypothesis that at 1 year post-intervention, a significantly greater proportion of the advanced-practice nurse (APN) phone counseling group will have undergone cardiovascular screening, as compared to the standard care group. Cardiovascular (CV) screening will be defined, based on established CV screening recommendations, as completion of an imaging evaluation of left ventricular systolic function (i.e., echocardiogram, multiple uptake gated acquisition scan, or cardiac magnetic resonance imaging).
  • This study will measure changes induced by the intervention in survivors' knowledge, motivation, fear, beliefs, affect, readiness for medical follow-up, and self-efficacy and these changes' potential mediating effects on CV screening.
  • This study will provide a cost analysis of the ECHOS intervention in terms of the cost of left ventricular systolic function imaging per additional survivor screened, an estimate of the cost of standard care per survivor screened, and the cost of screening and follow-up per survivor screened.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Childhood Cancer Survivor Study (CCSS) cohort participants
  • Age 25 years or older
  • No CV screening in previous 5 years
  • Received anthracycline chemotherapy and/or irradiation of the chest
  • Previous history of successful independent (non-surrogate) response to CCSS surveys (reading level for non-medical items is 4th-6th grade Flesch-Kincaid level).

Exclusion criteria

  • Being followed at an institution actively recruiting adults to a long-term follow-up program (ascertained in CCSS follow-up database)
  • Inability or unwillingness of research participant to give written informed consent.

Treatment and study plan

lifestyle modification and telephone counseling

Behavioral

A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).

Other names: Cardiovascular Health Outcomes

Primary outcomes

  1. This study will test the hypothesis that at 1 year post-intervention, a significantly greater proportion of the APN phone counseling group will have undergone cardiovascular screening, as compared to the standard care group

    Time frame: 2.5 years

Secondary outcomes

  1. Change in knowledge

    Time frame: Baseline and 2.5 years post intervention

  2. Change in motivation

    Time frame: Baseline and 2.5 years post intervention

  3. Change in fear

    Time frame: Baseline and 2.5 years post intervention

  4. Change in beliefs

    Time frame: Baseline and 2.5 years post intervention

  5. Change in affect

    Time frame: Baseline and 2.5 years post intervention

  6. Change in readiness for medical follow-up

    Time frame: Baseline and 2.5 years post intervention

  7. Change in self-efficacy

    Time frame: Baseline and 2.5 years post intervention

  8. Estimated average cost of intervention per participant

    Time frame: 2.5 years

  9. Estimated average cost of standard care per participant in the Control Arm

    Time frame: 2.5 years

  10. Estimated average cost of cardiovascular screening per participant in the Test Arm

    Time frame: 2.5 years

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: ECHOS

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 29, 2009
Registry last updated
Nov 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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